Bio Pharma Dive
SEPTEMBER 28, 2021
Outside trial data reviewers have attributed three cases of severe muscle weakness to Pfizer’s treatment, causing the company to change the design of its closely watched Phase 3 study.
Pharma Mirror
SEPTEMBER 28, 2021
Unfair competition arising in the pharmaceutical markets and the presence of a shadow sector require the protection of the brand’s interests and confirmation of quality for the end customer. In recent years, the reaction to this has been the emergence of intercorporate methods of protecting goods from counterfeiting. The regulators of specific countries of national projects have started to control counterfeit and falsification by creating complex systems that verify each unit of goods.
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Bio Pharma Dive
SEPTEMBER 28, 2021
The Japanese pharma and Biogen partner is filing an application for accelerated OK of lecanemab, which works similarly to the companies' controversially cleared Aduhelm.
Pharma Times
SEPTEMBER 28, 2021
Informa Pharma Intelligence (IPI) has found that some drug firms may withdraw up to 90% of their products from Northern Ireland, once the Brexit grace period has passed.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
SEPTEMBER 28, 2021
With Pfizer's and Moderna's vaccines broadly used, Sanofi says it will focus on its protein-based coronavirus candidate. The French pharma sees more promise for its mRNA work in influenza.
pharmaphorum
SEPTEMBER 28, 2021
An app to support people with cognitive disabilities, developed with clinicians at Barts Health NHS Trust, has started to be made available more widely to patients. The Hear Me Now app developed with UCLPartners and software company Maldaba is designed to improve quality of care for people with cognitive impairment, specifically adults with a learning disability.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
SEPTEMBER 28, 2021
Niigata, Japan – Amyotrophic lateral sclerosis (ALS) is an intractable neurological disease. Aging is a risk factor for the accumulation of TDP-43 (transduction responsive region DNA-binding protein of 43kDa) in the motor cortex. TDP-43 is a protein that tends to accumulate in increasing amounts, and the amount is strictly controlled by the splicing of TDP-43. […].
BioSpace
SEPTEMBER 28, 2021
?Gene therapy research delivers breakthroughs this week with a CRISPR-edited droplet that could lead to a cure for heart disease and the possibility of turning glial brain cells into neurons.
pharmaphorum
SEPTEMBER 28, 2021
Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of an effective shot for Lyme disease. New phase 2 data with their VLA15 vaccine shows that antibody responses from an initial three-dose regimen are initially high, although they start to decline after 18 months in adult subjects.
BioSpace
SEPTEMBER 28, 2021
Amicus Therapeutics is launching a next-generation genetic medicine company called Caritas Therapeutics, Inc. through a merger deal with ARYA Sciences Acquisition Corp IV.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
SEPTEMBER 28, 2021
Sanofi has said that it won’t develop its mRNA-based vaccine for COVID-19 any further, even though it seemed to work in an early-stage trial, and will focus instead on another candidate partnered with GlaxoSmithKline. The French pharma group said it took the decision because mRNA vaccines from Pfizer/BioNTech and Moderna are already widely available today it will be too late to the market with its candidate, which was originated by its partner Translate Bio.
FDA Law Blog
SEPTEMBER 28, 2021
By Kalie E. Richardson — On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. The U.S. Attorney’s Office (USAO) for the District of Puerto Rico and the Department of Health and Human Services, Office of Inspector General (HHS-OIG) announced both th
pharmaphorum
SEPTEMBER 28, 2021
As pharmaphorum’s founder, Dr Paul Tunnah, continues his Health Innovators video series, he connects with the co-founder of Iceland’s Sidekick Health, Saemundur “Sam” Oddsson. They discuss Sam’s journey from being a medical doctor to co-founder of a digital health company and some of the learnings along the way. Sam explains the purpose of Sidekick – and challenges it has encountered – in addressing one of the trickiest problems worldwide, which is why people are generally so bad at
Pharma Times
SEPTEMBER 28, 2021
Sanome, an early-stage biotech company based in London and Cambridge, has received support from health and biotech investors from the UK and Europe in its first round of funding.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioPharma Reporter
SEPTEMBER 28, 2021
ViroCell Biologics and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) have formed a new partnership to immediately address the global viral vector manufacturing bottleneck for clinical trials.
Scienmag
SEPTEMBER 28, 2021
[Vienna, September 28, 2021] In a crisis, women make significantly longer phone calls and adhere more closely to governmental measures than men; men are less likely to have their mobility restricted and return to normal more quickly than women. Researchers at the Complexity Science Hub Vienna (CSH) found cliché-sounding behavioral patterns like these in data […].
BioPharma Reporter
SEPTEMBER 28, 2021
Pfizer Inc has started a trial to evaluate its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.
NY Times
SEPTEMBER 28, 2021
The finding came from a study of Americans who got their third vaccine dose in August and September, and provided a reassuring sign about the safety of additional doses.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
BioPharma Reporter
SEPTEMBER 28, 2021
Neurophth Biotechnology Ltd. has opened a manufacturing facility at the Phase II Suzhou Biomedical Industrial Park (BioBAY) in Suzhou, China.
Outsourcing Pharma
SEPTEMBER 28, 2021
The pharmaceutical firm has tapped the decentralized research organization in order to help elevate the inclusivity of its oncology trials at all levels.
BioSpace
SEPTEMBER 28, 2021
?Expansion said much of the funds will go into its SMiRNA platform to find clinical candidates in myotonic DM1, FTD, ALS, and several other tauopathies.
Outsourcing Pharma
SEPTEMBER 28, 2021
Conducted by patient services specialist Greenphire, the survey checks in with contract research organizations and shows how they are approaching obstacles.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
BioSpace
SEPTEMBER 28, 2021
Reports emerged late Wednesday afternoon that Merck emerged as the winning suitor with a deal valued at about $11 billion.
Outsourcing Pharma
SEPTEMBER 28, 2021
Q BioMed reports it expects candidate MAN-19, intended to treat COVID-19-related Acute Respiratory Distress Syndrome, to enter trials early next year.
Scienmag
SEPTEMBER 28, 2021
Oncotarget published “Pan-drug and drug-specific mechanisms of 5-FU, irinotecan (CPT-11), oxaliplatin, and cisplatin identified by comparison of transcriptomic and cytokine responses of colorectal cancer cells” which reported that there was an increase in IL-8 by oxaliplatin and increase in ferritin by cisplatin which may contribute to cancer cell survival.
BioSpace
SEPTEMBER 28, 2021
As the 10th annual IDWeek (Infectious Disease Week) Conference begins, treatments aimed at COVID-19 will certainly dominate the program.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
NY Times
SEPTEMBER 28, 2021
Veterinarians, ranchers and farmers say they are struggling with the effects of the surging demand for ivermectin, a deworming drug.
Delveinsight
SEPTEMBER 28, 2021
Innovent, UNION Therapeutics Set to Advance Dermatology Market in China. Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast , a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China. Orismilast is a potent and selective, next-generation PDE4 inhibitor with broad anti-inflammatory properties.
BioSpace
SEPTEMBER 28, 2021
AstraZeneca’s Alexion plans to buy all remaining equity in Caelum Biosciences and pick up Caelum’s CAEL-101 in the process.
BioTech 365
SEPTEMBER 28, 2021
Incyte Names New Member to Its Board of Directors Incyte Names New Member to Its Board of Directors WILMINGTON, Del.–(BUSINESS WIRE)–$INCY–Incyte (Nasdaq:INCY) announces the appointment of Otis Brawley, M.D.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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